This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA). AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness. This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
VDPHL01 Extended Release (ER) Tablet
Placebo
Site 73
Birmingham, Alabama, United States
Site 89
Birmingham, Alabama, United States
Site 77
Phoenix, Arizona, United States
Site 69
Encino, California, United States
Site 64
Manhattan Beach, California, United States
Site 93
Northridge, California, United States
Changes in non-vellus Target Area Hair Counts (TAHC)
Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Time frame: Month 6
Subjects Evaluation of Treatment Benefit
Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.
Time frame: Month 6
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Site 66
Santa Monica, California, United States
Site 94
Thousand Oaks, California, United States
Site 71
Boca Raton, Florida, United States
Site 86
Coral Gables, Florida, United States
...and 34 more locations